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The ECOM (Endotracheal Cardiac Output Monitoring) System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.

The ECOM (Endotracheal Cardiac Qutput Monitoring) System consists of an ECOM Endotracheal Tube, which contains the electrodes, an ECOM Monitor, an ECOM Tube Cable, and a Laptop Computer. The ECOM System is used in conjunction with a commercially available arterial pressure (AP) line and 3 surface leads on the patient's chest for R-Wave Detection. The Instructions For Use in Appendix 1 includes pictures of each of these components. The ECOM System is intended for the continuous monitoring of cardiac output by a specially designed endotracheal tube using the principle of bioimpedance (impedance cardiography). Bioimpedance is based on the principal that all biological tissues. including blood, muscle, bone and fat, have electrical properties. Of these, blood is one of the most electrically conductive. Because arterial blood is pulsatile, changes in blood flow result in changes in electrical conductivity and hence the impedance of the blood to electrical current. The ECOM System measures impedance by injecting a small alternating electrical current (100kHz, 4.0mA) between a pair of electrodes located on the shaft and cuff of the ECOM Endotracheal Tube. Additional electrodes on the ECOM Endotracheal Tube sense the change of impedance caused by changes of the aortic blood flow. A proprietary ECOM algorithm is used to calculate ventricular stroke volume (SV) from the impedance and arterial pressure waveforms. The stroke volume is multiplied by the patient's heart rate (HR) to calculate cardiac output (CO) in liters per minute. In addition to these parameters, ECOM displays traces of the impedance waveforms, R-Wave Detection signals, systolic and diastolic arterial pressure. The ECOM Endotracheal Tube contains seven low profile, flexible electrodes affixed to the cuff and shaft of a Standard Endotracheal Tube. The close proximity of the endotracheal tube balloon cuff in relationship to the ascending aorta provides an optimal location from which to measure impedance changes resulting from aortic blood flow. The ECOM Endotracheal Tube is provided sterile for single use only. It will be available in 6.0mm to 9.0mm sizes, in 0.5mm increments. The ECOM Monitor, Laptop Computer, ECOM Tube Cable, Lead Wire, Arterial Pressure Cable. Cord Sets, Power Supply, and Power Conditioner are reusable and provided nonsterile.

SiteSelect® is a disposable, single use diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from its mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign. SiteSelect is to be used in conjunction with a stereotactic mammographic imaging system capable of determining position of lesion within breast tissue. This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

SiteSelect Breast Biopsy System consists of the SiteSelect device and the Site Select table mount accessories. We have previously received clearance under 510(k) # K972328 for the 10mm and 15mm SiteSelect device. We have since received clearance under 510(k) #K993963 to expand the intended use. The Instrument Accessories have received clearance under 510(k) # K972328 and are currently on the market. The SiteSelect device is provided sterile for single use only. It contains a Localization Needle, Localization Wire, a Stylet, and Cutting Cannula. The device is equipped with a Garrote Wire and Disc Blades to transect the specimen. The device is packaged in individual thermoformed blisters with peel off Tyvek® lid.

SiteSelect is a disposable, single use, diagnostic device used to obtain localized large core biopsies of breast tissue of a mammographic abnormality, identified by the placement of a needle/ localization wire, which is suspect to be malignant. The SiteSelect device is intended to provide tissue for histological examination with partial or complete removal of imaged lesions. The scope of a histological abnormality is not able to be determined from it's mammographic appearance. Therefore, it is essential that the tissue margins be examined for margin involvement and completeness of removal in cases where the tissue sample is not found to be benign. SiteSelect is to be used in conjunction with stereotactic mammographic imaging systems capable of determining position of lesion within breast tissue. This device is used in conjunction with the SiteSelect Instrument Accessories, which are mounted on a stereotactic table and used with a stereotactic mammographic imaging system.

The SiteSelect device, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These devices are marketed by Imagyn Surgical and United States Surgical Corporation (USSC). SiteSelect, Imagyn Surgical, and USSC devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are used with stereotactic mammographic imaging systems. The construction, materials, sterilization, and method of operation of the SiteSelect devices are identical to the Imagyn Surgical SiteSelect devices currently on the market. The major difference between SiteSelect and USSC ABBI devices is that the ABBI device removes tissue in route to and including the target area. The SiteSelect device obturates up to the lesion, leaving intact the tissue in route to the target area.